Study of effectiveness and safety on the hair loss restraint by scalp cooling with scalp cooling device in the breast cancer chemotherapy
Phase 2
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000031534
- Lead Sponsor
- ational Hospital Organization Kyushu Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 120
Inclusion Criteria
Not provided
Exclusion Criteria
1)Chilly allergy 2)Cold agglutinin disease 3)Any scalp skin tumor 4)History of radiation for head 5)Temporomandibular disorder or disease to a chin 6)Any other cases who are regarded as inadequate for study enrollment by the attending doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of grade 0 or 1 of hair loss, according to CTCAE ver4.0 classification
- Secondary Outcome Measures
Name Time Method Rate of hair loss restraint in each evaluation timing Hair loss accompanying symptom Hair loss period Safety Adverse events Influence of the hair loss after the chemotherapy